Who We Are
The Alliance for Safe Biologic Medicines is an organization of patients, physicians, pharmacists, biotechnology companies that develop innovative and biosimilar medicines and others, who are working together to ensure that patient safety is at the forefront of the biosimilars policy discussion. It is the mission of the Alliance to serve as an authoritative resource center of information for the public, medical community, the FDA and other state and federal policymakers during the implementation of the biosimilars approval pathway and beyond.
Our Perspective
Biologics are advanced prescription drugs to treat cancer, rheumatoid arthritis and other debilitating diseases. In November 2010 the Food and Drug Administration began consultation with patient groups, physicians and industry on how to approve the first copies of these drugs, known as follow-on biologics or biosimilars. As the FDA moves forward in implementing this pathway, the Alliance for Safe Biologic Medicines will work to ensure patient safety remains the priority.
| Health Canada Opens Consultation on Biosimilar Handbook for Healthcare Professionals
Health Canada has opened a consultation on its draft Handbook for healthcare professionals on biosimilar biologic drugs. This publication was developed for the purpose of informing and educating healthcare professionals in Canada regarding biosimilars. The handbook was developed in consultation with a working group composed of subject matter experts from Health Canada, and external healthcare professionals representing a range of professional associations.
The document covers numerous issues including: the differences between biosimilars and generic drugs, the regulation of biosimilars in Canada, monitoring the safety and effectiveness of biosimilars, the role of healthcare professionals in improving pharmacovigilance for biosimilars, and discussions about switching. Interested parties are invited to email comments to brddopic-bpcidmbr@hc-sc.gc.ca.
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| REGISTRATION OPEN: ASBM/GCCA Biosimilar Training Program
Registration is now open for the ASBM-sponsored Biosimilars Training Program which will be presented May 10-11, 2022 by the Global Colon Cancer Association, in partnership with the World Patient Alliance. The virtual event is open to patients from any disease state. Register here.
This two-day program will educate patients worldwide about biosimilars and equip them with the tools they need to be more effective advocates and help ensure their country’s biosimilar policies work for the patients they represent. Several ASBM representatives will be leading sessions, including:
Patient advocates from around the world will also share their biosimilar experiences and advocacy strategies. Join these and other speakers to learn about the benefits, as well as the new challenges biosimilars bring for patients.
Register for the Biosimilar Training Program here.
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| ASBM Adds Third CE Course to OSU College of Pharmacy Biosimilars Program.
On March 8th, ASBM Advisory Board Chair Philip Schneider recorded the third in an ongoing series of Continuing Education (CE) courses produced in partnership with Ohio State University College of Pharmacy’s Office of Continuing Professional Development.
The third entry, entitled “Biosimilar Pharmacovigilance”, examines the unique pharmacovigilance challenges that biosimilars pose due to having an abbreviated approval pathway, while simultaneously sharing a non-proprietary name with their reference product and other biosimilars to that product.
The importance of accurate attribution of adverse events is discussed, as are various approaches to addressing this challenge used by countries around the world to varying degrees of effectiveness. The U.S. biologic pharmacovigilance and nomenclature system is also examined in detail, as is the WHO-proposed international nomenclature standard.
The course is fully ACPE accredited and available to pharmacists nationwide.
View the OSU CE Courses here (registration required)
Visit the Ohio State University College of Pharmacy’s Office of Continuing Professional Development here.
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| ASBM Leads Sessions at Festival of Biologics USA 2022
From March 9-11, ASBM participated in the Festival of Biologics USA 2022, held in San Diego, California. Several ASBM representatives presented on a variety of topics, and participated in several discussion panels at the three-day conference.
On March 9th, ASBM Advisory Board Chair Philip Schneider gave a plenary presentation on the current biosimilars landscape, highlighting factors which are contributing to biosimilars gaining market share in the U.S. Among these are greater discounts resulting from increased competition, as well as greater physician confidence in biosimilars due to strong FDA data requirements and increased familiarity. View his presentation here.
On March 11th, Schneider gave a presentation in the conference’s “Real World Evidence” (RWE) track entitled “Problems with pharmacovigilance programs: Opportunities for improvement.” This presentation highlighted some of the unique pharmacovigilance challenges of biosimilars, areas of concern, and strategies for improving biosimilar pharmacovigilance globally. View this presentation here: Part 1 Part 2
Following his presentation, Schneider moderated one of the conference’s two closing panel discussions, entitled “Promoting biosimilar uptake”. This discussion examined the impact of interchangeable biosimilars on the biosimilar landscape and the role of competition in an increasingly active biosimilars pipeline.
The second closing panel discussion was moderated by ASBM Steering Committee Member Andrew Spiegel, Executive Director of the Global Colon Cancer Association. It is entitled “Market access dynamics and the future across different therapeutic areas” and will examine (e.g. arthritis, oncology, opthalmology, hematology, etc).
One topic of this discussion was the possibility of switching patients at the Veterans Health Administration (VHA) en masse to preferred biosimilars, in order to realize cost savings across a large health system. Mr. Spiegel raised concerns with this approach, citing a recent study published in the journal Current Medical Research and Opinion, which examined US VHA patients who were switched from innovator infliximab to the VHA-preferred biosimilar. The study found that those who were switched from the reference product to the biosimilar were almost 3 times more likely to stop treatment and 5 times more likely to switch to another innovator biologic.
The study also found that 91% of the patients who stopped the biosimilar switched back to the originator product. “Reasons for discontinuation and switching are unknown,” investigators wrote in the study.
Learn more about the Festival of Biologics USA 2022 here.
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| Bill Would Eliminate Requirement For Biosimilars to Have Equal Strength as Originator Biologics
On March 9th, a bill was introduced in the U.S. House of Representatives that would eliminate the requirement for a biosimilar to have the same strength as the originator product upon which it is based.
H.R. 7047, the “Lowering Costs by Improving Biosimilar Uptake Act”, would amend title III of the Public Health Service, permitting the Secretary of Health and Human Services to waive this approval requirements:
(I) The Secretary may determine, in the Secretary’s discretion, that an element described in clause (i)(I), or in clause (i)(IV) with respect to the strength of a biological product, is unnecessary in an application submitted under this subsection.
In addition to having the same benefits, potential side effects, and route of administration and the originator product- biosimilars are currently requiredto have the same dosage and strength as the reference product.
The bill has been referred to the U.S. House Energy and Commerce Committee. ASBM will continue to monitor its progress.
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| ASBM Chair Participates in DDNC Policy Forum, Urges Passage of Safe Step Act
From March 6th-8th, the Digestive Disease National Coalition (DDNC) held its 32nd Annual Public Policy Forum, the theme of which was “Putting Patients First.” The focus of the meeting was to connect the gastrointestinal disease community and advocate with congressional leaders with a common agenda. There were over 200 participants from 33 states and Washington, DC. ASBM Chairman Ralph McKibbin, MD, a past President of DDNC, participated in the policy forum as part of the Pennsylvania state team.
A key legislative priority discussed at the Forum was the Safe Step Actcurrently before the U.S. House and Senate. Step therapy is a utilization management technique commonly used by health plans to limit access to expensive medications such as biologic for chronic diseases; but there are no standardized guidelines for the practice. This has been shown to lead to increased patient and system costs, delays in care, and worse patient outcomes. S 464/HR 2163, the Safe Step Act, would:
During the forum, DDNC held nearly 80 virtual congressional meetings to connect with their legislators, share their patients’ stories, and advocate for their legislative priorities including the Safe Step Act. Read more about the Safe Step Act here.
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| HHS Inspector General Announces Study of Biosimilars in Medicare Part B
The Inspector General for the U.S. Department of Health and Human Services has announced a study of use and cost trends of biosimilars and their reference biologics covered by Part B over time. From the announcement:
In addition to examining use and cost trends, it will also determine how much Medicare and beneficiaries paid for biosimilars and reference biologics covered by Part B in 2021, and then compare those costs to determine how much Part B and beneficiaries could have spent with increased use of biosimilars or with different reimbursement policies.
Read the HHS Inspector General’s announcement here.
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| UPCOMING ASBM EVENTS
ASBM/GCCA Biosimilars Training Program Virtual – May 10-11, 2022
DIA Global Annual Meeting 2021 Chicago, Illinois – June 19-23, 2022
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